Label: ASPIRIN- aspirin tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 14, 2018

If you are a consumer or patient please visit this version.

  • ​Active ingredient (in each tablet)

    Aspirin 81 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug 

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  • Purpose

    Pain reliever 

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  • Uses

    Temporarily relieves minor aches and pains.

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  • Warnings

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product.  When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert: Aspirin may cause a severe allergic reaction, which may include:  

    • hives
    • facial swelling
    • shock
    • asthma (wheezing)

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.  The chance is higher if you:

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • have 3 or more alcoholic drinks every day while using this product
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • take more or for a longer time than directed

    Do not use

    if you are allergic to aspirin or any other  pain reliever/fever reducer.

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis or kidney disease
    • you have asthma
    • you are taking a diuretic

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug for

    • gout
    • diabetes
    • arthritis 

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:
      • feel faint
      • have bloody or black stools
      • vomit blood
      • have stomach pain that does not get better
    • an allergic reaction occurs. Seek medical help right away.
    • new symptoms occur
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • ringing in the ears or loss of hearing occurs 

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. 

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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  • Directions

    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
    • children under 12 years: do not use unless directed by a doctor 
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  • Other information

    • store at controlled room temperature 20º-25ºC (68º-77ºF)
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  • Inactive ingredients

    anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium,FD&C red # 40 aluminum lake,FD&C yellow # 6 aluminum lake,  iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80,  simethicone, sodium hydroxide, sodium lauryl sulfate, talc, triethyl citrate

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  • Questions or comments?

    1-800-632-6900 

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  • Principal Display Panel

    Compare to the active ingredient of St. Joseph® Aspirin

    †See back panel

    Aspirin 81 mg

    Pain Reliever(NSAID)

    Low Dose

    Aspirin Regimen≠

    Enteric Safety-Coated** Tablets

    †St. Joseph® Aspirin is a registered trademark of St. Josephs Health Products, LLC, Irvington, NY 10533. St. Josephs health Products, LLC, is not affiliated with The Kroger Co. or this product.

    **Coating helps protect against stomach upset

    ≠Talk to your doctor before starting an aspirin regimen. Aspirin is not right for everyone.

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY THE KROGER CO.

    CINCINNATI, OHIO 45202

    www.kroger.com

    GLUTEN FREE

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  • Product Label

    Aspirin 81 mg

    Kroger Aspirin 81 mg Tablets

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  • INGREDIENTS AND APPEARANCE
    ASPIRIN 
    aspirin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-104
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code heart
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30142-104-18 1 in 1 CARTON 06/30/2014 12/31/2020
    1 180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 06/30/2014 12/31/2020
    Labeler - The Kroger Co. (006999528)
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